C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-02-12 for C6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX 101256901 manufactured by Applied Medical.

Event Text Entries

[5494372] Lap chole- "normal procedure but smoke evac stuck on position and inadvertently sucked up bowel. " type of intervention- "doctor greet extremely unhappy with product and wanted to escalate to cpac committee to change supply. " patient status- "stable. "
Patient Sequence No: 1, Text Type: D, B5


[12894689] Investigation summary: the incident product was not returned for evaluation and no lot number was provided. In the absence of the subject device, it is difficult to determine the root cause of the incident. All final assembled handpieces are leak tested at both suction and irrigation valves to ensure the seal functions properly. Through user's interaction with the handpiece, the smoke evacuation feature may have been unintentionally activated. Applied medical continuously seeks to improve the form, function, and ease of use of its products. As part of this continuous process, applied medical has recently re-designed the handpiece which is intended to minimize the potential for this type of incident to occur. This document represents both our initial/final report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027111-2015-00032
MDR Report Key4513597
Report Source01,05,06,07
Date Received2015-02-12
Date of Report2015-02-12
Date of Event2014-08-01
Report Date2014-09-02
Date Reported to Mfgr2014-09-02
Date Added to Maude2015-02-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone949713-823
Manufacturer G1APPLIED MEDICAL
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal Code92688
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameC6001, 5MMX33CM PROB/VALV DUAL BAG 12/BX
Generic NameFHF
Product CodeFHF
Date Received2015-02-12
Model NumberC6001
Catalog Number101256901
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-02-12

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